Combination regimens of 3 active drugs have shown promising activity in treatment of metastatic gastric cancer. Docetaxel combined with cisplatin and 5-fluorouracil (FU) yielded superior overall survival and response rates when compared to standard cisplatin and 5-FU. However, a toxicity profile showed the need for development of less toxic modifications. In a prior phase I trial, the maximum tolerated dose was defined. In this phase II trial, a first evaluation of activity will be performed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Docetaxel: 35 mg/m2, IV day 1, 8 of each 21 day cycle; Oxaliplatin: 70 mg/m2, IV day 1, 8 of each 21 day cycle; Capecitabine: 2x800 mg/m2 PO IV day 1 evening till morning of day 15 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Charite - Universitatsmedizin Berlin
Berlin, Germany
Medizinische Universitätsklinik - Knappschaftskrankenhaus
Bochum, Germany
Städtische Kliniken Esslingen
Esslingen am Neckar, Germany
MVZ Osthessen
Progression-free survival rate
Time frame: at 6 months
Number of Participants with Adverse Events as a Measure of Safety/toxicity
Time frame: 2 years
Median time to progression
Time frame: 2 years
Response rate
Time frame: 2 years
Rate of resections with curative intent
Time frame: 2 years
Time to treatment failure
Time frame: 2 years
Duration of response
Time frame: 2 years
Median overall survival
Time frame: 2 years
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Fulda, Germany
Martin-Luther-University Halle-Wittenberg
Halle, Germany
Städt. Klinikum St. Georg
Leipzig, Germany
OSP Lörrach-Rheinfelden
Loerrach, Germany
Universitätsklinikum Mainz
Mainz, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Universitätsklinik Ulm
Ulm, Germany